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Biologist, Chemist, Pharmacist as Supply Chain Manager - CMO Management, IMP, IND, (m/w/d) - TZ-980716

ITM Isotopen Technologien München AG

ITM Medical Isotopes GmbH

ITM Medical Isotopes GmbH is a subsidiary of ITM Isotopen Technologien München AG, a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing a range of cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are directly located in the heart of the research center of the Technical University of Munich (TUM).

We would like to fill the following vacancy as soon as possible:

Supply Chain Manager Third Party Management (f/m/d)

  • Manages outsourced production, labelling, packaging and distribution of IMP’s (Investigational Medicinal Products) at established pharmaceutical CMO`s
  • Sourcing of new qualified CMO´s for IND’s (Investigational New Drugs)
  • Full responsibility for negotiation of supply contracts with vendors or CMOs, from start to signature
  • CMO Management includes supply planning management, cost and resource planning, operational set up, outsourcing, surveillance, performance management and budget/cost control
  • Representation of TPM function within a matrix organisation and interdisciplinary teams including Project Management, Business Leadership, Quality Assurance, Quality Control, Engineering, Validation, Manufacturing and Regulatory Affairs
  • Review of protocols, batch records, specifications, reports, regulatory filings, SOP`s (Standard Operating Procedures) in collaboration with QA & Regulatory teams
  • Development of SOP`s and continuous improvement of clinical trial supply processes and global supply chain
  • Graduation from a German or foreign institution of higher education (university level) preferably in Life Science, e.g. Chemistry, Biology or Pharmaceutics. Additional logistics experience would be an asset
  • At minimum 3 years of professional GMP experience in a clinical trial supply or CMC environment of the pharmaceutical, radiopharmaceutical or medical technology industry
  • Thorough understanding of GMP and ICH standards governing IMP labelling, packaging and distribution. Additional GCP experience would be an asset
  • Further practical experience in the field of manufacturing, quality control, project management or radiation protection advantageous
  • Strong problem-solving capabilities
  • Flexibility, resilience, assertiveness, customer and results-orientation and a high degree of organization and communication skills
  • Proficient in use of common MS Office application (Word, Excel etc.)
  • Willingness to travel internationally (20%)
  • Fluent in German and English, both written and spoken
  • A modern workplace and exciting opportunities in the development of technologies with a secure future
  • Cross-border intercultural cooperation and short communication channels
  • A collegial corporate culture
  • An attractive salary package and diverse corporate benefits

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